Serious Adverse Drug Reaction and Their Preventability

NCT02888834 | Completed

• 1 other identifier: 2015Ao008
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Introduction: Elderly aged over 65 years accounted for around 17.5% of the French general population. Adverse drug reactions (ADR) are common in this population. In elderly subject, prevalence of ADRs ranged from 4.3% to 63.0%. Aim: To describe the serious ADR in elderly subjects aged over 65 years and assess their preventability. Methods: A retrospective study was conducted at the Regional Pharmacovigilance Center of Champagne-Ardenne (northeast of France) between January and May 2013. Patients aged over 65 years who presented a serious ADR notified to the Regional Pharmacovigilance Center were included in the study.

Conditions

Adverse Drug Reaction

Keywords

elderly; adverse drug reactions; hospitalized subjects; community-dwelling

Outcome Measures

Primary Outcomes (1)

• The different type of serious ADR were coded according to Medical Dictionary for Regulatory Activities (MedDRA version 16.0) according to lowest-level terms (LLTs), and then grouped by system organ class (SOC).

  9 months

Secondary Outcomes (3)

• Drugs involved in the occurrence of serious ADR

  9 months

• Evolution were classified as "recovered", "not yet recovered", "recovered with sequelae" , "death" , "unknown"

  9 months

• Preventability was assessed by using the preventability French scale.

  9 months

Study Arms (1)

Adverse drug reaction

Patients aged over 65 years who presented a serious adverse drug reaction notified to the Regional Pharmacovigilance Center of Champagne-Ardenne between January and May 2013 were included in the study.

Other: Adverse drug reaction

Interventions

Adverse drug reaction OTHER

Adverse drug reaction

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who presented an adverse drug reaction notified to the Regional Pharmacovigilance Center of Champagne-Ardenne.

You may qualify if:

• Patients aged over 65 years
• Patients who presented a serious adverse drug reaction notified to the Regional Pharmacovigilance Center of Champagne-Ardenne

Sponsors & Collaborators

• CHU de Reims: lead

Study Sites (1)

Chu de Reims

Reims, France, 51092, France

Location

Related Publications (1)

• Kanagaratnam L, Abou Taam M, Heng M, De Boissieu P, Roux MP, Trenque T. [Serious Adverse Drug Reaction and Their Preventability in the Elderly Over 65 Years]. Therapie. 2015 Sep-Oct;70(5):477-84. doi: 10.2515/therapie/2015029. Epub 2015 Jun 26. French.

  PMID: 26223243 BACKGROUND

MeSH Terms

Conditions

Drug-Related Side Effects and Adverse Reactions

Interventions

Adverse Drug Reaction Reporting Systems

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders

Intervention Hierarchy (Ancestors)

Product Surveillance, Postmarketing; Evaluation Studies as Topic; Investigative Techniques; Drug Information Services; Pharmaceutical Services; Health Services; Health Care Facilities Workforce and Services

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 19, 2016
• First Posted: September 5, 2016
• Study Start: January 1, 2013
• Primary Completion: May 1, 2013
• Study Completion: October 1, 2013
• Last Updated: September 5, 2016

Record last verified: 2016-08

Locations

FR (1)